ID

16100

Description

Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02315495

Link

https://clinicaltrials.gov/show/NCT02315495

Keywords

Versions (1)
  1. 6/29/16 6/29/16 -
Uploaded on

June 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02315495

English

Eligibility Type 2 Diabetes NCT02315495

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes (world health organisation (who) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
Description

Diabetes Mellitus, Non-Insulin-Dependent Diabetic on diet only | Oral hypoglycemic Absent | Insulin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0421246
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021641
UMLS CUI [3,2]
C0332197
body mass index (bmi) 20 - 40 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
age 18 - 70 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
Description

Gender | Postmenopausal state | control Menstrual cycle Effect Gut Hormone secretion

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0243148
UMLS CUI [3,2]
C0025329
UMLS CUI [3,3]
C1280500
UMLS CUI [3,4]
C0699819
UMLS CUI [3,5]
C0312431
glycated haemoglobin a1c (hba1c) ≥ 6.0% and ≤ 7.9%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
haemoglobin above the lower limit of the normal range (i.e. >135g/l for men and 115g/l for women), and ferritin above the lower limit of normal (i.e. >10mcg/l)
Description

Hemoglobin measurement | Gender | Ferritin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0373607
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of any medication that may influence gastrointestinal motor function, body weight or appetite
Description

Pharmaceutical Preparations Affecting function gastrointestinal motor | Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting appetite

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0031843
UMLS CUI [1,4]
C0521362
UMLS CUI [1,5]
C1513492
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0005910
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0003618
evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
Description

Drug abuse | Alcohol consumption Unit per Gram per Day | Cigarette smoker Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C2349072
UMLS CUI [3,1]
C0337667
UMLS CUI [3,2]
C3694146
history of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
Description

Gastrointestinal Diseases | Symptoms Significant Upper Gastrointestinal Tract | Symptoms Significant Lower Gastrointestinal Tract | Pancreatitis | Gastrointestinal Surgical Procedure | Appendectomy Uncomplicated | Cholecystectomy Uncomplicated

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C3203348
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0750502
UMLS CUI [3,3]
C0226875
UMLS CUI [4]
C0030305
UMLS CUI [5]
C0524722
UMLS CUI [6,1]
C0003611
UMLS CUI [6,2]
C0443334
UMLS CUI [7,1]
C0008320
UMLS CUI [7,2]
C0443334
other significant illness, including epilepsy, cardiovascular or respiratory disease
Description

Illness Significant | Epilepsy | Cardiovascular Diseases | Respiration Disorders

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0035204
autonomic nerve damage (as assessed by standardised cardiovascular reflex tests [36])
Description

Autonomic nerve injury

Data type

boolean

Alias
UMLS CUI [1]
C0560614
impaired renal or liver function (as assessed by calculated creatinine clearance < 90 ml/min or abnormal liver function tests (> 2 times upper limit of normal range))
Description

Renal Insufficiency | Liver Dysfunction | Creatinine clearance measurement | Liver function tests abnormal

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0086565
UMLS CUI [3]
C0373595
UMLS CUI [4]
C0151766
allergy to vildagliptin or any other 'gliptin'
Description

Hypersensitivity vildagliptin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1570906
donation of blood within the previous 3 months
Description

Blood Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
participation in any other research studies within the previous 3 months
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
females who are pre-menopausal
Description

Premenopause

Data type

boolean

Alias
UMLS CUI [1]
C0206158
inability to give informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
vegetarians
Description

Vegetarian

Data type

boolean

Alias
UMLS CUI [1]
C0042441
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Similar models

Eligibility Type 2 Diabetes NCT02315495

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent Diabetic on diet only | Oral hypoglycemic Absent | Insulin Absent
Item
type 2 diabetes (world health organisation (who) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin)
boolean
C0011860 (UMLS CUI [1,1])
C0421246 (UMLS CUI [1,2])
C0359086 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021641 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Body mass index
Item
body mass index (bmi) 20 - 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Age
Item
age 18 - 70 years
boolean
C0001779 (UMLS CUI [1])
Gender | Postmenopausal state | control Menstrual cycle Effect Gut Hormone secretion
Item
males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion)
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0243148 (UMLS CUI [3,1])
C0025329 (UMLS CUI [3,2])
C1280500 (UMLS CUI [3,3])
C0699819 (UMLS CUI [3,4])
C0312431 (UMLS CUI [3,5])
Hemoglobin A1c measurement
Item
glycated haemoglobin a1c (hba1c) ≥ 6.0% and ≤ 7.9%
boolean
C0474680 (UMLS CUI [1])
Hemoglobin measurement | Gender | Ferritin measurement
Item
haemoglobin above the lower limit of the normal range (i.e. >135g/l for men and 115g/l for women), and ferritin above the lower limit of normal (i.e. >10mcg/l)
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0373607 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Affecting function gastrointestinal motor | Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting appetite
Item
use of any medication that may influence gastrointestinal motor function, body weight or appetite
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0031843 (UMLS CUI [1,3])
C0521362 (UMLS CUI [1,4])
C1513492 (UMLS CUI [1,5])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0005910 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0003618 (UMLS CUI [3,3])
Drug abuse | Alcohol consumption Unit per Gram per Day | Cigarette smoker Number of cigarettes per day
Item
evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
boolean
C0013146 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C2349072 (UMLS CUI [2,2])
C0337667 (UMLS CUI [3,1])
C3694146 (UMLS CUI [3,2])
Gastrointestinal Diseases | Symptoms Significant Upper Gastrointestinal Tract | Symptoms Significant Lower Gastrointestinal Tract | Pancreatitis | Gastrointestinal Surgical Procedure | Appendectomy Uncomplicated | Cholecystectomy Uncomplicated
Item
history of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
boolean
C0017178 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C3203348 (UMLS CUI [2,3])
C1457887 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0226875 (UMLS CUI [3,3])
C0030305 (UMLS CUI [4])
C0524722 (UMLS CUI [5])
C0003611 (UMLS CUI [6,1])
C0443334 (UMLS CUI [6,2])
C0008320 (UMLS CUI [7,1])
C0443334 (UMLS CUI [7,2])
Illness Significant | Epilepsy | Cardiovascular Diseases | Respiration Disorders
Item
other significant illness, including epilepsy, cardiovascular or respiratory disease
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0014544 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
Autonomic nerve injury
Item
autonomic nerve damage (as assessed by standardised cardiovascular reflex tests [36])
boolean
C0560614 (UMLS CUI [1])
Renal Insufficiency | Liver Dysfunction | Creatinine clearance measurement | Liver function tests abnormal
Item
impaired renal or liver function (as assessed by calculated creatinine clearance < 90 ml/min or abnormal liver function tests (> 2 times upper limit of normal range))
boolean
C1565489 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0151766 (UMLS CUI [4])
Hypersensitivity vildagliptin
Item
allergy to vildagliptin or any other 'gliptin'
boolean
C0020517 (UMLS CUI [1,1])
C1570906 (UMLS CUI [1,2])
Blood Donation
Item
donation of blood within the previous 3 months
boolean
C0005794 (UMLS CUI [1])
Study Subject Participation Status
Item
participation in any other research studies within the previous 3 months
boolean
C2348568 (UMLS CUI [1])
Premenopause
Item
females who are pre-menopausal
boolean
C0206158 (UMLS CUI [1])
Informed Consent Unable
Item
inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Vegetarian
Item
vegetarians
boolean
C0042441 (UMLS CUI [1])
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